Kurzfassung

A randomized, open label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positiev locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy
Primary Objective:
To demonstrate the superiority of rogaratinib over chemotherapy in terms of prolonging overall survival of urothelial carcinoma patients with FGFR positive tumors
Secondary Objectives:
To evaluate...A randomized, open label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positiev locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy
Primary Objective:
To demonstrate the superiority of rogaratinib over chemotherapy in terms of prolonging overall survival of urothelial carcinoma patients with FGFR positive tumors
Secondary Objectives:
To evaluate additional efficacy including the following variables:
- progression-free survival (PFS)
- objective response rate (ORR)
- disease control rate (DCR)
- duration of response (DOR)» weiterlesen» einklappen